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NCT07455747From ClinicalTrials.govRecruiting

Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System

Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System (ENTRUST)

  • Extracranial Carotid Artery Disease
  • TCAR
  • Transcarotid Artery Revascularization

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Boston Scientific Corporation
Enrolment target
5,000
Started
19 August 2026
Main results due
May 2028
Study sites
1
Registry updated
23 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Patient is ≥ 18 years of age\*
* Written informed consent (patient data-release form)
* Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease and specified in the Registry Enrollment Guide(s).

  * Refer to the Registry Enrollment Guide for details on enrollment restrictions based on patient age

Exclusion Criteria:

* Life expectancy of \< 1 year or patient is unlikely to derive net clinical benefit from carotid revascularization.
* Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

What this study is about

In the sponsor’s own words, from the registry.

The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of Transcarotid Artery Revascularization (TCAR) in patients with extracranial carotid artery disease are inadequately reported.

Study sites(1)

  • St. Luke's Episcopal-Presbyterian Hospital

    St Louis, Missouri, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07455747. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection Sys | Trialion